The Determination Of Residual Solvents In Pharmaceuticals With Static Headspace Gas Chromatography

This paper consists of four chapters.In Chapter One, the basal principle, methodology applications and prospects of the Static Headspace Gas Chromatography are reviewed. It is emphasized that Static Headspace Gas Chromatography is used for various volatile residual solvents in Pharmaceuticals.In Chapter Two, Study of effecting factors on Static Headspace Gas Chromatography. Described theory of static headspace gas chromatography by determination of ethanol and benzene in water. Effect of gas-liquid phase ratio, distribution constant, equilibrium temperature, equilibrium time and salt on sensitivity of static headspace gas chromatography were discussed. The results show that effect of these factors on the sensitivity of static headspace gas chromatography is varied significantly with various volatile residual solvents in pharmaceuticals.In Chapter Three, Determination of Alcohol Residue in Diammonium Glycyrrhizinate by Open-tubular Column Gas Chromatography. An analytical method of head-space Open-tubular Column gas chromatography was described for the determination of alcohol residue in Diammonium Glycyrrhizinate. The factors influencing the analysis, such as flow rate, column temperature, split ratio, gas-liquid equilibrium time and temperature were discussed. The experimental results showed that the detection limits were 2.028μg·mL^-1, relative standard deviation was 2.7% and the recoveries were 99.5%～114.0%. The proposed method is simple, sensitive, rapid and accurate.In Chapter Four, Fast Analysis of Borneolum in HuanYou by Packed Column Gas Chromatography. A new method of borneolum analysis of Chinese traditional petent medicine, HuanYou was established, using a 2m×3mm i.d. PEG-20M packed column. Fast separation of HuanYou can be achieved in a period less than 4.0 min. To compare with the other methods the analysis time was shortened to more than 50 percent. Test solution and reference solution were prepared by the same procedure. The method is simple, accurate and reasonable. It has practical value for the quality control of HuanYou.